Associate Scientific Director

## About the Role The Associate Scientific Director role at Biogen is a unique opportunity to join a team of experts dedicated to transforming the lives of patients with severe immune-mediated diseases. As a lead in Clinical Pharmacology, you will play a critical role in the development and execution of clinical pharmacology plans for drug candidates. You will work closely with cross-functional teams, including program and study teams, to provide strategic leadership and integrate knowledge of clinical and quantitative pharmacology. The role is based in South San Francisco, but can also be fully remote, allowing candidates to work from anywhere in the US.

The successful candidate will have a deep understanding of clinical pharmacology, including the development and execution of clinical pharmacology plans, and the ability to integrate knowledge of clinical and quantitative pharmacology to optimize and provide rationale for dosage regimens and study designs. You will be responsible for defining key milestones and decisions within the clinical pharmacology development plan, identifying risks and mitigation strategies, and leading the execution of clinical pharmacology studies and analyses.

As a key member of the team, you will work closely with cross-functional partners, consultants, experts, and vendors to achieve program goals and provide deliverables in approved timeframes. You will also be responsible for maintaining cutting-edge knowledge of best regulatory practices, quantitative/clinical pharmacology methodology, and drug development precedent.

## What You Will Do - Provide clinical pharmacology expertise to program and study teams throughout a molecule’s lifecycle - Develop and implement the clinical pharmacology development plan, considering all aspects (strategic, scientific, translational, and clinical) - Define key milestones and decisions within the clinical pharmacology development plan and identify risks and mitigation strategies - Lead execution of clinical pharmacology studies and analyses, interpret results, and recommend action based on results - Conduct hands-on quantitative analysis and present findings to multidisciplinary project teams - Serve as lead author and key contributor to clinical pharmacology sections of documents - Serve as the subject matter expert in interactions with Health Authorities - Seek input from and ensure alignment with cross-functional partners, consultants, experts, and vendors as needed - Work with program and/or study teams to achieve program goals and provide deliverables in approved timeframes

## What We Are Looking For - PhD or MD/PhD in Pharmacology, Pharmacokinetics, Pharmaceutics, or PharmD, or other suitable related fields - 5+ years of relevant industry experience (clinical pharmacology and/or clinical PK/PD) - Ability to analyze and interpret PK and PK/PD data utilizing sound scientific principles - Experience with designing and implementing relevant elements of clinical studies and/or dedicated Clinical Pharmacology studies - Ability to develop Clinical Pharmacology strategy in the context of the broader development paradigm - Knowledge of and ability to apply appropriate regulatory and ICH guidelines with regard to the acquisition, analysis, and interpretation of clinical pharmacology data - Proficiency with use of PK/PD software packages such as Phoenix, R, NONMEM

## Nice to Have - Experience with developing and implementing Quantitative Systems Pharmacology (QSP) models, and/or population PK, PKPD, exposure-response analyses - Experience with Model Informed Drug Development (MIDD) paired meeting program - Proficiency with Monolix and MATLAB

## Benefits and Perks - Competitive base salary - Eligibility for participation in Biogen’s LTI grants and other incentive programs - Full range of benefits, including medical, dental, life, long and short-term disability insurances, vacation, and end-of-year shutdown - Opportunity to work on novel targeted therapies and make a meaningful impact on patients' lives - Collaborative and dynamic work environment with a team of experts - Flexible working arrangements, including remote work options

- Make sure to highlight your experience with PK/PD software packages, such as Phoenix, R, and NONMEM, in your application.

• Emphasize your ability to analyze and interpret PK and PK/PD data, and provide examples of your experience in this area.
• Be prepared to discuss your knowledge of regulatory and ICH guidelines, and how you have applied them in previous roles.
• If you have experience with Quantitative Systems Pharmacology (QSP) models or Model Informed Drug Development (MIDD), be sure to highlight this in your application.
• Research Biogen's company culture and values, and be prepared to discuss how your own values and work style align with theirs.
• Practice your presentation skills, as you will be required to present findings to multidisciplinary project teams.